Clinical trial · Expanded Access

Expanded Access Program for Pirtobrutinib for Participants With B-Cell Cancer

Expanded Access Program for Pirtobrutinib for Previously Treated B-Cell Cancers

NCT05172700CI-TRIAL-00083881approved for marketingClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

This is an expanded access program for eligible participants with a previously treated B-cell cancer who are ineligible for an ongoing pirtobrutinib clinical trial. The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.

Conditions

Conditions (5)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Leukemia, Lymphocytic, Chronic, B-Cell	Leukemia	ONTOLOGY_EXACT	0.85
Lymphoma, Lymphocytic, Small	Lymphoma	ONTOLOGY_EXACT	0.85
Lymphoma, Mantle-Cell	Mantle Cell Lymphoma	ONTOLOGY_EXACT	0.98
Ritcher's Transformation, Syndrome	—	UNRESOLVED	—
Waldenstrom Macroglobulinemia	Waldenstrom Macroglobulinemia	ONTOLOGY_EXACT	0.98

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Pirtobrutinib	Drug	Pirtobrutinib	ALIAS

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

* Have been diagnosed with:

  * CLL or SLL and have received treatment with the following five classes of therapy: Chemotherapy, anti-cluster of differentiation (anti-cd) 20 antibody, covalent Bruton's tyrosine kinase (BTK) inhibitor, B-cell lymphoma-2 (BCL-2) inhibitor, and phosphatidylinositol 3-kinase (PI3K) inhibitor
  * MCL that has been previously treated with a covalent BTK inhibitor
  * Richter's Transformation (RT) with previous Richter's directed-therapy
  * Waldenstrom macroglobulinemia (WM), previously treated with chemotherapy, anti-CD20 antibody and a covalent BTK inhibitor
* Are not eligible for an ongoing pirtobrutinib clinical trial

Exclusion Criteria:

* Inadequate organ function
* Significant cardiovascular disease
* History of allogenic or autologous stem cell transplant (SCT) or chimeric antigen receptor modified Tcell (CAR-T) therapy within 60 days
* Tested positive for human immunodeficiency syndrome (HIV) or known active hepatitis B or C virus or cytomegalovirus (CMV) infection
* Active, uncontrolled autoimmune cytopenia
* Clinically significant active malabsorption syndrome
* Participants requiring therapeutic anticoagulation with warfarin or another vitamin K antagonist

References

Publications (0)

Data not yet available

No reference posted for this study.